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Welcome to Headway’s first quarterly update. We look forward to sharing news about our company, accomplishments, developments, and team.
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| Headway pilot clinical trial kickoff |
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We now have a pilot clinical trial underway with OcciflexTM, our non-invasive professional device for treating chronic head and neck pain.
Thus far, we recruited 7 out of the 10 patients for the pilot trial, which began on June 09. The remaining three have been screened and are expected to begin treatment in early- to mid-August. The first patient in the pilot to complete the full 12 sessions is expected to receive her last treatment this week.
In the trial, each patient undergoes two 20-minute treatment sessions per week, over six weeks, for a total of 12 treatments. The treatment includes slow oscillations (0.5-2°/sec) on the sagittal plane for different ranges of motion (20°-40°). The movements are tailored for each patient's needs.
As of this update, we have completed about 60 (50%) of the total 120 sessions (12 sessions x 10 patients).
The results so far are very promising. There have been no adverse effects. Of the five patients treated at least three times, three reported improvement (reduced pain, improved cervical range of motion, improved quality of life, less pain medication, improved sleep, and / or generally feeling better). Some patients fell asleep during treatment, which means the patients felt relaxed enough to “let go.” As Dr. Yaron River, Headway’s founder and medical director, explains, “Although these are initial results, there is a good chance that the technology could be relevant for sleep disorders in the future.”
We are very pleased with the results and hope the rest of the trial continues along this positive path.
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| Future plans |
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As we move ahead with product development and business development, we have set a number of milestones for the next three quarters.
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Organize a meeting with relevant Israeli physiotherapists and researchers to receive feedback and ideas for future trials
(Q3 09).
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Complete the pilot (Q3 09).
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Analyze and publish the data (Q4 09).
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Submit two more trials: (1) A second pilot to prove the safety of the coronal and horizontal planes of movement. The Helsinki application to be submitted in Q4 09. (2) A pivotal efficacy trial to be designed and submitted following discussion with medical advisory board members and other medical personnel
(Q4 09 – Q1 10).
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Business development
Headway signs MOU (Memorandum of Understanding) with a leading European physiotherapy and rehab firm. Under the agreement, the two companies will jointly develop and manufacture an advanced product for the physiotherapy market, with the funding coming mainly from the European firm. Enraf-Nonius, the Dutch developer and supplier of physiotherapy and rehab products, will acquire international distribution rights.
For more info click here.
Upon signing the MOU, our private investor decided to invest another $100K. |
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| Intellectual property |
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We reached the national phase for our patent and submitted applications in the United States, Europe, Australia, and Korea. Next year, we plan to submit another application in Canada.
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| Biomed Exhibition |
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In June, we participated in the annual Biomed Israel conference in Tel Aviv. The conference, with 6,500 attendees, is a major scientific and business event. |
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As a direct result of Biomed, we made initial contact with some major players in the medical device field to explore joint ventures and collaborations. These discussions are still in the early stages, but we are encouraged by the interest from potential partners and investors.
In advance of Biomed, we updated our company brochure.
See the updated version.
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If you know of others who might be interested in Headway and our progress, and who may want to receive our quarterly updates, contact Tamir Levital.
If you do not want to receive updates in the future, send me an e-mail.
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